Overview
Iovance seeks an experienced and highly motivated Clinical Systems Manager to join our healthcare organization. As a Clinical Systems Manager, you will play a pivotal role in managing and optimizing our clinical systems and technology infrastructure. You will be responsible for overseeing and guiding the implementation, maintenance, and continuous improvement of clinical systems, ensuring their seamless integration and functionality across the organization. The successful candidate will possess a strong background in healthcare information systems, excellent leadership skills, and a passion for enhancing clinical trial operations through the effective use of technology.
Essential Functions and Responsibilities
· Clinical Systems Oversight:
- Develop and implement strategies for the effective management and optimization of clinical systems within the organization.
- Collaborate with cross-functional teams to assess clinical system requirements and identify opportunities for system enhancements and upgrades.
- Ensure the integration and interoperability of clinical systems such as eTMF, CTMS, LMS and Chain of Identity/Chain of Custody (COI/COC).
- Monitor system performance, identify issues, and develop strategies for system optimization and improvement.
- Stay up to date with industry trends, emerging technologies, and regulatory requirements related to clinical systems.
- Collaborate with cross-functional teams to identify opportunities for improvement and advancement of the systems landscape at Iovance.
· Implementation and Upgrades:
- Drive the planning, coordination, and execution of clinical system implementations and upgrades, including system configuration, testing, and end-user training.
- Collaborate with internal stakeholders, such as clinical staff, IT teams, and executive leadership, to ensure successful system implementations that meet organizational goals and requirements.
- Develop and maintain project plans, timelines, and resource allocations for clinical system implementation projects.
- Lead change management activities to support implementation, and updates of system changes
- Ensure adherence to best practices and standards throughout the implementation process.
· User Support and Training:
- Provide/enable expert-level support and troubleshooting for clinical system users, addressing technical issues and ensuring user satisfaction.
- Develop and deliver comprehensive training programs for clinical staff, ensuring their proficiency in using clinical systems effectively and efficiently.
- Create user documentation, training materials, and standard operating procedures (SOPs) to facilitate system utilization and standardization.
· User Administration
- Develop processes for compliant user onboarding, regular review, and offboarding
- Partner with IT to ensure regular system audits to assess security vulnerabilities & potential risks.
- Assist in the development and implementation of disaster recovery and business continuity plans.
· System Security and Compliance:
- Collaborate with IT security teams to implement robust security measures and protocols for clinical systems, ensuring compliance with privacy and security regulations (21 CFR, Part 11).
· Vendor Management:
- Establish and maintain strong relationships with clinical system vendors, ensuring effective communication, contract and budget management, as well as vendor performance evaluation.
- Collaborate with IT and vendors to resolve system-related issues, manage system upgrades and enhancements, and leverage vendor expertise for system optimization.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Travel
Required Education, Skills, and Knowledge
- Minimum of 9 years of experience with a bachelor’s degree in a relevant field (e.g., Life Sciences, Information Management); or 6 years with a Master’s degree; or 3 years with a PhD of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused on clinical system implementation, management, and oversight.
- In-depth knowledge of healthcare information systems, such as eTMF, CTMS, COI/COC, LMS.
- Demonstrated understanding of the clinical drug development process and clinical trial methodology
- Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical systems
- Demonstrated ability to assess current and future business needs to ensure the clinical systems function is strategically and operationally positioned to properly support the Clinical Development and Logistics organizations.
- Demonstrated leadership ability
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent project management skills with a track record of successful system implementations and upgrades.
- Preferred experience with system configuration, testing, and training.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams.
- Strong knowledge of clinical trial processes, regulations (e.g., ICH-GCP, 21 CFR Part 11), and document management best practices. Able to attend off-site meetings/training/conferences as needed
Fit with IOVANCE culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with IOVANCE's Core Values
- Excitement about the vision and mission of IOVANCE
- Flexibility
- Integrity
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
#LI-remote
